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Corporate Accountability
Hims & Hers Health, Inc. · Class Action · 2024–2026
Hims & Hers Sold an Untested Weight Loss Drug While Lying About What Was in It
The telehealth giant told hundreds of thousands of consumers its compounded semaglutide contained the same active ingredient as Ozempic and Wegovy. Independent testing confirmed it did not. The FDA agreed.
TL;DR
Hims & Hers sold hundreds of thousands of consumers a weight loss injection it advertised as containing “the same active ingredient as Ozempic and Wegovy.” That claim was false. The company’s product was manufactured using a cheap chemical synthesis process that produces a fundamentally different collection of peptide molecules, none of which have ever been tested for safety or effectiveness, and none of which have ever been reviewed by the FDA. The health consequences of injecting those unknown peptides include immune reactions, inflammation, anaphylaxis, and the potential destruction of the effectiveness of real Ozempic or Wegovy if a consumer tries to take it later. Hims & Hers knew the difference. They advertised the lie anyway. The FDA confirmed the deception in a September 2025 warning letter. This is not a technicality. Consumers injected an untested substance into their bodies because a publicly traded company chose profit over honesty.
Demand accountability: share this story, support the class action, and report misleading telehealth advertising to the FDA at 1-800-FDA-1088.
$199
Per month charged to consumers out of pocket
$5M+
Minimum amount in controversy (class action threshold)
100+
Estimated class members (likely hundreds of thousands)
0
FDA evaluations of Hims & Hers product for safety or efficacy
Sept 2025
Date FDA formally called the advertising “false or misleading”
May 2024
Date Hims & Hers first launched the deceptive product
⚠ The Allegations: What They Did
Core Allegations
What they did · 7 points
▾
| 01 | Hims & Hers advertised its compounded semaglutide product as being made with “the same active ingredient as Ozempic and Wegovy” across both hims.com and forhers.com from at least May 2024 through the date of the lawsuit filing in February 2026. This statement was false. | high |
| 02 | Hims & Hers’s product uses a synthetic chemical manufacturing process, not the biological recombinant DNA process Novo Nordisk uses to make the actual semaglutide in Ozempic and Wegovy. These are fundamentally different processes that produce fundamentally different substances. | high |
| 03 | Independent testing confirmed Hims & Hers’s active ingredient contains peptides, including peptides with missing, extra, substituted, or truncated amino acid sequences, that are not present in Ozempic or Wegovy at all. | high |
| 04 | The product has never been meaningfully tested for safety or effectiveness. No clinical trials were conducted on it. The FDA has never evaluated it. Hims & Hers’s prescribers nonetheless sent consumers copy-and-paste messages stating the medication was “proven to reduce appetite and promote weight loss,” which is false. | high |
| 05 | Hims & Hers’s product also contains benzyl alcohol, a chemical not found in Ozempic or Wegovy. The company has never tested whether benzyl alcohol interacts adversely with the unique peptides in its product. | high |
| 06 | Novo Nordisk does not sell its semaglutide active ingredient to any other company. Any “compounded semaglutide” sold by any third party, including Hims & Hers, uses a different substance made by a different supplier through a different process. | med |
| 07 | Despite a September 2025 FDA warning letter formally declaring the advertising “false or misleading,” Hims & Hers continued running substantially similar ads on Facebook as late as November 2025, well after receiving the federal warning. | high |
Public Health and Safety
Unsafe product, known health risks · 6 points
▾
| 01 | The foreign peptides in Hims & Hers’s product can trigger immunogenicity, meaning the consumer’s own immune system mounts a response against the injected substance. This can cause rash, flu-like symptoms, inflammation, or anaphylaxis. | high |
| 02 | Cross-reactivity from the immune response can extend to authentic Ozempic and Wegovy. Consumers who take Hims & Hers’s product and later attempt to use the FDA-approved drugs may find them less effective or experience serious side effects. | high |
| 03 | The immune response can also cross-react with the consumer’s own naturally occurring GLP-1 hormone, a substance the body depends on for glucose regulation. This could cause serious and potentially irreversible metabolic harm. | high |
| 04 | FDA guidance explicitly warns that chemical synthesis of peptides can lead to insertion, deletion, or modification of amino acid sequences that “create the potential for differences in immunogenicity or may otherwise affect the safety or effectiveness of a peptide drug product.” | high |
| 05 | Even seemingly small amounts of novel peptide impurities can have significant health consequences, particularly after repeated injections over time, and are well-documented as causing safety risks in other peptide active ingredients. | med |
| 06 | Neither plaintiff ever spoke to a physician before, during, or meaningfully after purchasing the product. The purported “prescriber” review was an automated copy-and-paste approval, not a medical consultation. Consumers had no professional guidance about these health risks. | high |
Profit Over People
Revenue prioritized over consumer safety · 5 points
▾
| 01 | The synthetic chemical manufacturing process used by Hims & Hers is significantly cheaper and easier than Novo Nordisk’s biological recombinant DNA process, giving Hims & Hers a financial incentive to use it while advertising the product as equivalent to the more expensive, rigorously tested alternatives. | high |
| 02 | Hims & Hers’s 2025 Super Bowl commercial promoting the product drew formal objections from U.S. senators and the FDA’s own commissioner for misleading consumers. The company ran the ad anyway, demonstrating that regulatory and congressional alarm did not outweigh advertising ambition. | high |
| 03 | Hims & Hers paid celebrity influencers including Miley Cyrus, Jennifer Lopez, Rob Gronkowski, and Alex Rodriguez to promote the brand, while investing heavily in television, social media, radio, billboards, and paid search advertising. The scale of this campaign was specifically designed to funnel consumers to the misleading website claims. | med |
| 04 | Hims & Hers does not accept health insurance or any government health program. Every consumer paid 100% out of pocket, with no third-party payor to independently review the product or flag the misleading claims. This structure maximized revenue while eliminating a key check on consumer deception. | med |
| 05 | Hims & Hers knew that consumers would not inject an untested, unregulated substance into their bodies if told the truth about what it was. The company’s own advertising strategy was built on that knowledge: the deception was not accidental but deliberate. | high |
Corporate Accountability Failures
Regulatory gaps, no oversight, no transparency · 5 points
▾
| 01 | Hims & Hers exploited a regulatory gap intended for small-scale, local compounding pharmacies. Modern internet commerce, sophisticated logistics, and a globalized supply chain allowed the company to scale this practice to hundreds of thousands of consumers in ways the original drug compounding laws never anticipated. | high |
| 02 | The FDA’s warning letter took over a year to arrive after the product launched in May 2024. During that entire period, Hims & Hers continued advertising the product with the same false “same active ingredient” claim on its homepage, FAQ section, and smartphone app. | high |
| 03 | Two peer-reviewed scientific studies published detailed differences between chemically synthesized semaglutide and the biologically produced active ingredient in Ozempic and Wegovy. Hims & Hers’s product was likely among those studied. The company did not update its advertising in response to this published science. | med |
| 04 | At no point in the purchasing process did any Hims & Hers prescriber disclose the different active ingredient, the different manufacturing process, the different peptide content, or the health risks to either named plaintiff or, according to the complaint, any class member. | high |
| 05 | The complaint alleges unjust enrichment: Hims & Hers collected full payment for a product it falsely described, and consumers received a product they either would not have purchased at all or would have paid far less for had they known the truth. | med |
🕐 Timeline of Events
May 2024
Hims & Hers first launches its compounded semaglutide product on hims.com and forhers.com, advertising it as containing “the same active ingredient as Ozempic and Wegovy.”
Aug 2024
Web archive confirms both hims.com and forhers.com prominently feature the “same active ingredient” claim in the main weight loss menu, before any consumer interaction with a prescriber.
Feb 6, 2025
Plaintiffs Andrew Donoho and Gloria Ferguson each purchase the product independently, relying on the false advertising. Neither speaks to a physician. Both enter credit card information before any prescriber contact.
Feb 7, 2025
U.S. Senators Durbin and Marshall formally write to the FDA demanding action against Hims & Hers’s Super Bowl advertisement for misleading consumers about risks associated with compounded semaglutide.
Apr 29, 2025
Novo Nordisk submits a formal letter to the FDA, documenting that chemically synthesized compounded semaglutide is “meaningfully different” from its FDA-approved active ingredient and petitioning the FDA to restrict compounding of semaglutide.
Sept 9, 2025
The FDA issues formal warning letters to both Hims (hims.com) and Hers (forhers.com), concluding that the advertising claims are “false or misleading” and that they falsely imply the products are the same as FDA-approved drugs.
Nov 2025
Despite the September FDA warning, Hims & Hers runs Facebook advertisements containing substantially the same misleading “same active ingredient as Ozempic and Wegovy” claim.
Feb 20, 2026
Class action complaint filed in the U.S. District Court for the Northern District of Illinois on behalf of plaintiffs Donoho and Ferguson, representing all U.S. purchasers of the product. Jury trial demanded.
💬 Direct Quotes from the Legal Record
QUOTE 1
The core lie, in their own words
Core Allegations
“Hims & Hers consistently advertises this product as being made with ‘the same active ingredient’ as the weight loss and diabetes drugs Ozempic and Wegovy. That is false.”
💡 This is the central allegation of the entire complaint: that Hims & Hers’s foundational advertising claim, repeated across its homepage, FAQ, app, and social media, was simply untrue.
QUOTE 2
Consumers would have paid less or not bought it
Profit Over People
“If Hims & Hers told consumers the truth… then consumers would either not buy the product or they would pay far less for it.”
💡 This passage establishes the direct financial motive for the deception: the lie was worth money. Truth would have destroyed or severely undercut the market for the product.
QUOTE 3
Novo Nordisk confirms: not the same
Core Allegations
“The semaglutide bulk drug substance used by compounders is not the same semaglutide used in [Novo Nordisk’s] FDA-approved medicines… the compounders use active pharmaceutical ingredients that are manufactured by chemical synthesis.”
💡 This is Novo Nordisk’s own language in a formal FDA submission. The manufacturer of the real drug explicitly confirmed that what Hims & Hers sold was a different substance.
QUOTE 4
The prescriber’s false “proven” claim
Accountability Failures
“The medication I’m prescribing you is proven to reduce appetite and promote weight loss.”
💡 This copy-and-paste prescriber message, sent to both plaintiffs, falsely implied clinical studies backed the product. No such studies exist. Only Wegovy has been clinically proven for weight loss, not Hims & Hers’s product.
QUOTE 5
FDA formally calls it false or misleading
Regulatory Failures
“These claims are false or misleading” and “imply that your products are the same as an FDA-approved product when they are not.”
💡 These are the FDA’s own words in its September 2025 warning letters to Hims and Hers separately. A federal regulator confirmed the deception in writing, months before this lawsuit was filed.
QUOTE 6
Immune system damage: the worst case scenario
Public Health and Safety
“Cross-reactivity can extend to endogenous GLP-1. If this happens, the consumer’s own immune system can target the consumer’s own naturally occurring GLP-1, leading to serious health consequences.”
💡 This describes a scenario in which the untested peptides in Hims & Hers’s product cause a consumer’s immune system to attack their own body. This is not hypothetical; it is a documented immunological risk.
QUOTE 7
No physician contact before purchase
Accountability Failures
“Mr. Donoho never spoke to a physician or other health care provider before purchasing the product. At no point in the purchasing process, did any prescriber ever discuss any other drug options, risks, nor the composition of the product in any way.”
💡 The complaint documents this for both plaintiffs. The “prescriber” in the Hims & Hers model is a rubber stamp, not a safeguard. Medical authority is invoked to lend credibility while providing zero actual medical protection.
QUOTE 8
Systemic regulatory exploitation
Regulatory Failures
“Modern technological advances in internet-based commerce, sophisticated logistics, and a globalized supply chain allow scale and reach never imagined when the drug laws were passed.”
💡 This passage explains how Hims & Hers exploited a loophole designed for small local compounding pharmacies and used it to reach hundreds of thousands of consumers nationally with an untested drug product.
💬 Commentary
Is Hims & Hers’s product actually dangerous, or is this just a labeling dispute?
▾
This is not a labeling dispute. The complaint documents that the product contains peptide molecules never present in Ozempic or Wegovy, that those peptides have never been tested for safety, and that they carry documented risks of immune reactions up to and including anaphylaxis. Beyond that, the immune response those unknown peptides can trigger may permanently compromise the effectiveness of real semaglutide if a consumer later needs it, and in the most severe scenario, may cause the consumer’s immune system to attack their own body’s GLP-1 hormone. Consumers who injected this product did not know what they were putting into their bodies. That is a public health problem, not a paperwork problem.
Why did it take so long for the FDA to act?
▾
The complaint reveals a structural enforcement failure. The compounding framework that Hims & Hers exploited was designed for small-scale, individualized pharmacy work and was never built for internet-scale direct-to-consumer pharmaceutical sales. The FDA had to navigate complex regulatory territory while Hims & Hers ran Super Bowl ads and paid celebrity endorsers. U.S. senators raised the alarm in February 2025. The formal warning letter did not arrive until September 2025, and even then, the company continued running misleading ads in November 2025. This is what happens when enforcement timelines cannot keep pace with corporate advertising budgets.
Didn’t Hims & Hers have a real licensed prescriber review each case?
▾
The complaint is direct: neither plaintiff ever spoke to a prescriber. Both submitted their credit card information before any contact with a “licensed provider.” Both received identical copy-and-paste approval messages containing the same false claim: that the medication was “proven to reduce appetite and promote weight loss.” The prescriber step in the Hims & Hers model exists to satisfy legal form, not to protect patients. A prescriber who sends a form letter without discussing product composition, risks, or alternatives is not providing medical care. The company used the appearance of medical oversight to launder a purchasing decision that consumers had already made based on advertising.
Is the lawsuit likely to succeed?
▾
I am not a lawyer and this is not legal advice. What the record shows is substantial: independent laboratory testing confirming the product differs from what was advertised, two peer-reviewed scientific publications documenting the differences, a formal FDA warning letter calling the advertising “false or misleading,” and a formal submission from Novo Nordisk itself confirming the active ingredients are not the same. The plaintiffs also have documented purchase records, documented reliance on the specific false claims, and a statutory basis under the Illinois Consumer Fraud and Deceptive Trade Practices Act plus similar statutes in California and New York. The evidentiary foundation appears strong.
What can I do to prevent this from happening again?
▾
Several concrete actions matter. If you purchased Hims & Hers’s compounded semaglutide, contact Polivick Law Firm (information in the complaint) to determine if you are eligible to join the class action. Report any misleading health product advertising directly to the FDA at 1-800-FDA-1088 or via MedWatch at fda.gov/medwatch. Contact your congressional representative and ask them to support stronger oversight of direct-to-consumer telehealth pharmaceutical advertising. Share this story so that other consumers understand what is in these products before injecting them. Never purchase a compounded prescription drug without first asking your actual physician whether the product has been tested independently and whether it carries the same active ingredient as the brand-name version. Demand transparency, not convenience.
Why does the manufacturing process matter if both products contain semaglutide?
▾
The scientific principle at stake is summarized in the complaint’s citation of a peer-reviewed source: “the process defines the product.” Biological recombinant DNA manufacturing, which Novo Nordisk uses, produces extremely pure copies of the semaglutide peptide with very few impurities. Chemical synthesis, which Hims & Hers uses, produces the semaglutide molecule alongside other peptides with missing, extra, substituted, or truncated amino acid sequences. Those extra peptides are not inert filler. They are foreign molecules injected into a human body that the immune system has never encountered and for which no safety testing has been done. Both products contain semaglutide, but they are not the same product, in the same way that a pharmaceutical-grade aspirin and aspirin mixed with unidentified additional compounds are not the same product.
Hims & Hers marketed to people desperate to lose weight. Does that context matter?
▾
It matters enormously. The complaint notes that reasonable consumers trust pharmaceutical companies to accurately describe their products, have little experience with unregulated compounded drugs, and cannot independently evaluate claims about drug composition or safety. Hims & Hers targeted this population specifically: people who wanted the benefits of Ozempic or Wegovy but could not access or afford the real drugs. The company then exploited the trust consumers place in medical-looking products, pharmaceutical language, and the appearance of prescriber oversight. Targeting a medically vulnerable population with a false claim about an injected substance is not aggressive marketing. It is exploitation of desperate people by a company that knew exactly what it was doing.
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